Recently the FDA approved the one and only injectable product for preterm labor, Makena. It was previously approved by the FDA in February of 2011 but the manufacturer, KV Pharmaceuticals, was NOT granted FDA exclusivity due to the price and accessibility of the drug. Instead, the FDA allowed compounding pharmacies to make an injectable of the active ingredient, hydroxyprogesterone caproate (aka 17P). However, the FDA has overturned its prior ruling and Makena is now the only FDA-approved medication that helps reduce the risk for another preterm birth in women who have delivered a prior baby too early in the past.
When should Makena be used?
Administration of Makena should be started between weeks 16 and 20 of pregnancy and continued once per week until week 37 or delivery.
Who administers the injection?
A qualified healthcare provider—most likely at your OB/GYN office—will give you this injection.
What is the usual dose of Makena?
1 mL (250 mg) is injected intramuscularly every 7 days in the upper–outer quadrant of the gluteus maximus (yup, this shot is given in your behind).
I used to get this medication at a compounding pharmacy—now what?
Unfortunately, compounding pharmacies are no longer allowed to compound this medication since it is now commercially manufactured. However, it will now be available at a specialty pharmacy.
Can I get Makena at a retail pharmacy instead?
No. The prescription process for Makena is managed through the manufacturer support program, Makena Care Connection, and it will need to be obtained from a specialty pharmacy. Usually, a specialty pharmacy will be assigned to you by your pharmacy benefit if you have insurance; they are often mail order pharmacies that you will never set foot in. The specialty pharmacy takes care of your prescriptions from A to Z—they get the prescription from your doctor’s office, take care of any authorizations that may be needed, fill the prescription, and ship it to your house or the doctor’s office for administration.
Is there financial assistance available for Makena?
Yes. Assistance is available for clinically eligible insured and uninsured patients upon request. You can find more information about the program here.